MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE; ANESTHESIA GAS MACHINE

Model Number 1009-9002-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Awareness during Anaesthesia (1707); Intraoperative Pain (2662)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

Ge healthcare was notified that a patient experienced awareness and/or recall and was not able to communicate with the care provider during a laparoscopic band removal procedure.The patient stated that they could feel pain and/or pressure and/or the actual procedure being performed.The patient alleges to have sustained severe and permanent injuries and emotional trauma.

Manufacturer Narrative

This event was alleged to have occurred on or about (b)(6) 2017.At that time, a third party service provider performed a checkout of the system with no faults found and no parts replaced.The device logs were not preserved thus not available for analysis.The unit was placed back into service after checkout.Ge healthcare (gehc) was notified of this event via pending litigation on 28-feb-2019.Gehc product engineering performed an investigation of this event.Due to the pending litigation, information from the user is not available.A search of the complaint database was conducted for complaints from 1-jan-2017 through 31-dec-2017 documenting other issues for avance serial number (b)(4).One previous complaint (gehc complaint number (b)(4)) was the only complaint found.(b)(4) was for the avance failing checkout before patient use due to a leak in an unidentified tec 7 vaporizer; there was no patient impact since the vaporizer leak was found during checkout.(b)(4) was reported to have occurred on 03-apr-2017 near the 30-mar-2017 timeframe, but the complaint does not indicate if the vaporizer leak prevented anesthetic agent delivery.Since vaporizers are moved from anesthesia machine to anesthesia machine, this investigation cannot correlate the (b)(6) 2017 patient issue to the (b)(6) 2017 (b)(4) complaint.Furthermore, this investigation cannot assume an unquantified leak from an unidentified vaporizer is the root cause for no anesthetic agent delivery.Therefore, the root cause is undetermined.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8455173
• MDR Text Key: 139960380
• Report Number: 2112667-2019-00021
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K032803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1009-9002-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other